2025 data FDA MAUDE openFDA FDA Class I

Cleanser, Denture, Over The Counter

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.3520 (Dental panel).

FDA MAUDE casebook

openFDA event book Cleanser, Denture, Over The Counter LIGHT-BOOK · MAUDE

#745 of 1000 · 776 reports · 1997–2025

  • BOOK 776 reports
  • RANK #745 of 1000
  • DEATH 32 death-typed
  • INJ 580 injury-typed
  • MALF 8 malfunction
  • SPAN 1997–2025
  • PEAK 2017: 83
  • PHOTO Electrocautery

Nearest event-volume peer: Electrocautery, Gynecologic (And Accessories) (1 report gap)

Cleanser, Denture, Over The Counter sits #745 of 1000 among tracked device types with 776 MAUDE reports spanning 1997–2025. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Similar-volume device →

Malfunction reports sit below the device-type norm

Cleanser, Denture, Over The Counter carries 1.0% MALFUNCTION-coded reports, 63.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.1% corpus 1.5% · above corpus mean (+2.6 pp)
  • INJ 74.7% corpus 30.3% · above corpus mean (+44.4 pp)
  • MALF 1.0% corpus 64.8% · below corpus mean (-63.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 44% of coded problems · Top event location I is 53% of location-tagged rows .

Cleanser, Denture, Over The Counter in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Cleanser, Denture, Over The Counter carries 776 MAUDE reports, ranked #745 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 580 (74.7%)
Other 132 (17.0%)
Death 32 (4.1%)
24 (3.1%)
Malfunction 8 (1.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Other 598 (69.3%)
Hospitalization 90 (10.4%)
O 52 (6.0%)
Death 32 (3.7%)
28 (3.2%)
R 21 (2.4%)
Life Threatening 15 (1.7%)
Required Intervention 10 (1.2%)
S 6 (0.7%)
H 4 (0.5%)
Disability 4 (0.5%)
D 2 (0.2%)
L 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 346
Improper or Incorrect Procedure or Method 148
Insufficient Device Problem Information 82
Patient-Device Incompatibility 56
Unknown (for use when the device problem is not known) 44
Use of Device Problem 40
Product Quality Problem 11
Device Operates Differently Than Expected 10
Reaction 9
Appropriate Device Problem Term/Code Not Available 6
Human-Device Interface Problem 5
Off-Label Use 4
Break 3
Inadequate User Interface 3
Patient Device Interaction Problem 3
Biocompatibility 2
Device Handling Problem 2
Device Markings/Labelling Problem 2
Labelling, Instructions for Use or Training Problem 2
Nonstandard Device 2

Yearly Trend

97
1997: 1
98
1998: 2
99
1999: 3
00
2000: 1
01
2001: 9
02
2002: 1
03
2003: 3
04
2004: 17
05
2005: 11
06
2006: 8
07
2007: 9
08
2008: 12
09
2009: 17
10
2010: 12
11
2011: 25
12
2012: 18
13
2013: 31
14
2014: 13
15
2015: 20
16
2016: 67
17
2017: 83
18
2018: 79
19
2019: 55
20
2020: 68
21
2021: 74
22
2022: 40
23
2023: 44
24
2024: 42
25
2025: 11

Reports in 2024 (42) held close to the prior two-year average of 42.

Related Entities for Cleanser, Denture, Over The Counter

Event Locations

I 414 (53.4%)
334 (43.0%)
NO INFORMATION 20 (2.6%)
HOME 7 (0.9%)
HOSPITAL 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Cleanser, Denture, Over The Counter: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (776 here).

Similar death-typed counts

Nearest other device types by death-typed report count (32 here), distinct from the volume row.

Disclaimer: MAUDE figures for Cleanser, Denture, Over The Counter are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Cleanser, Denture, Over The Counter; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.